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news, analysis, debates, commentary and camaraderie related to the development of biotechnology drugsFri, 16 Feb 2018 17:01:46 +0000en-UShourly1http://wordpress.org/?v=3.5He Said What?!?! Best Biotech Quotes of 2011http://www.bioworld.com/perspectives/2011/12/29/he-said-what-best-biotech-quotes-of-2011/
http://www.bioworld.com/perspectives/2011/12/29/he-said-what-best-biotech-quotes-of-2011/#commentsThu, 29 Dec 2011 19:26:45 +0000Trista Morrisonhttp://www.bioworld.com/perspectives/?p=721As BioWorld Insight readers know, our “Word on the Street” column provides a sample of the most entertaining and thought-provoking quotes our staff stumbles upon each week. Some are gathered during interviews, some gleaned from analyst reports, and some overheard...

]]>As BioWorld Insight readers know, our “Word on the Street” column provides a sample of the most entertaining and thought-provoking quotes our staff stumbles upon each week. Some are gathered during interviews, some gleaned from analyst reports, and some overheard at conferences. As we kick off 2012, here’s a look back at some of the quotes that defined 2011:

On Business

“Biotech is all about picking the exception. Granting access to capital to everyone doesn’t strike me as the right idea.”

‑ Bob More, general partner with Frazier Healthcare Ventures, taking an optimistic view on capital constraints. Private biotechs continued to struggle in 2011, raising about as much money as in 2010.

"I think we're going to see a regression to quality."

‑ Jim Healy, general partner at Sofinnova Ventures, on how the venture contraction will mean that only the highest quality companies get funded. Several venture groups pulled out of biotech investing during 2011.

“The take-home message is that it’s easy to build a $25 million company with $100 million cash.”

‑ Tillman Gerngross, CEO of Adimab LLC, on the trend of sliding valuations post-initial public offering. Although a handful of biotechs went public in 2011, the window did not open as wide as some had hoped.

"You can't save your way to success in this business."

‑ Marina Biotech Inc.'s CEO Michael French on the tough financial choices small biotechs must make, such as accepting harsh terms to keep a company moving forward.

“Monday, I was in Chicago, presenting at ASCO. Tuesday, I’m in California, pitching at Goldman (Sachs). And Wednesday, I’m in New York, presenting at Jefferies. How many red-eye medallion miles does it take to get one deal?”

‑ A jet-lagged biopharma CEO, taking a break at the Jefferies 2011 Global Healthcare Conference, and illustrating just how hard biotechs had to work to close financings and partnerships in 2011

On Science

“What happens when the next 10 patients you see require eight different drug combinations based on the mutations in their tumors?”

‑ Outgoing ASCO president George Sledge, on the exponential increases in complexity required to tackle “chaotic” tumors with high mutational load. Personalization of medicine continued to be a theme at ASCO and AACR in 2011.

"You do have to be somewhat of a Talmudic scholar to prescribe this drug."

]]>http://www.bioworld.com/perspectives/2011/12/29/he-said-what-best-biotech-quotes-of-2011/feed/0The Good, the Bad and . . . the Huh? A 2011 Biotech Recaphttp://www.bioworld.com/perspectives/2011/12/28/the-good-the-bad-and-the-huh-a-2011-biotech-recap/
http://www.bioworld.com/perspectives/2011/12/28/the-good-the-bad-and-the-huh-a-2011-biotech-recap/#commentsWed, 28 Dec 2011 22:11:41 +0000Jennifer Boggshttp://www.bioworld.com/perspectives/?p=713The past year brought the biotech sector a mixed bag of news. Some of it was positive – for instance, the FDA picked up its drug approval pace in 2011 and, in some cases, even surprised the most hardened biotech...

The past year brought the biotech sector a mixed bag of news. Some of it was positive – for instance, the FDA picked up its drug approval pace in 2011 and, in some cases, even surprised the most hardened biotech investors by granting approval of some drugs a month or two before their PDUFA dates – while other headlines hailed discouraging trends such as the failure of Prospect Ventures to close its latest round, confirming predictions of a venture capital contraction.

As we get ready to head into 2012 (and possibly an apocalyptic count-down, if those Mayans are to be believed), let’s take a look back at some of the highs and lows of the biotech industry in 2011.

‘Me-First’ Instead of ‘Me-Too’

Biotech execs always talk about tackling unmet medical needs. So it was exciting to see in 2011 the flurry of breakthrough drugs hitting the market. An informal BioWorld poll tagged Seattle Genetics Inc.’s lymphoma drug Adcetris (brentuximab vedotin), the first approved antibody-drug conjugate, as the biggest drug approval of the year, tied with HCV game-changers Incivek (telaprevir) from Vertex Pharmaceuticals Inc. and Victrelis (boceprevir) from Merck & Co. Inc. But other notable approvals included Human Genome Sciences Inc.’s Benlysta (belimumab), the first lupus drug approved in 50-plus years, and Yervoy (ipilimumab) from Bristol-Myers Squibb Co. and Zelboraf (vemurafenib) from Roche AG and Daiichi Sankyo Co. Ltd. as the first two drugs approved for melanoma that actually improved overall survival in clinical testing. And, late in the year, Incyte Corp. scored a win with Jakafi (ruxolitinib), the first approved JAK inhibitor and the first drug for myelofibrosis.

Let’s all hope that trend of “firsts” continues in 2012.

A ‘Nobel’ Death

In a bit of irony (in an Alanis Morissette kind of way), the Nobel committee awarded one-half of the 2011 Nobel prize in physiology or medicine to Ralph Steinman, unaware that the Rockefeller University professor had died of pancreatic cancer three days earlier. Posthumous Nobels are unusual but, after brief debate, the committee wisely decided to allow Steinman to remain a Nobelist. And I’m glad. He certainly earned the title for his discovery of the dendritic cell and its role in adaptive immunity. Plus, according to BioWorld’s science editor, Anette Breindl, who heard Steinman speak in 2007, he was a pretty nice guy.

Best Bang for the Buck?

The biggest M&A deal in 2011 was easily Sanofi SA’s $20-billion-plus-contingent value rights buyout of Genzyme Corp., which followed nine months of often less-than-friendly negotiations. But it wasn’t the best deal for biotech investors. Genzyme shareholders already have lost out on the $1 CVR connected to manufacturing capacity for enzyme replacement therapies Cerezyme and Fabrazyme. Whether they will be able to earn the remaining $13 linked to multiple sclerosis drug Lemtrada (alemtuzumab) is up for debate, and, for the most part, analysts are not optimistic.

If I were to choose, I’d say that Daiichi Sankyo Co. Ltd.’s bid for Plexxikon Inc. and Shire plc’s buyout of Advanced BioHealing Inc. were far more successful M&A deals. Daiichi’s hefty $935 million payment for Plexxikon – a move validated when Zelboraf gained approval in August – came despite only getting U.S. co-promotion rights to the melanoma drug under Plexxikon’s existing partnership with Roche AG. The Shire/ABH deal, meanwhile, showcased the kind of investor returns rarely seen these days. The big pharma firm shelled out $750 million for ABH, a whopping 15x return for ABH’s largest shareholder.

‘Weighed’ Down by Safety

Despite health experts clamoring for new ways to treat the so-called obesity epidemic, drugs aimed at helping people lose weight have not had an easy time of it at the FDA. Industry observers had expected 2011 to usher in not one, but three obesity therapies; instead, all three were rejected by the FDA. Orexigen Inc.’s Contrave got stalled on cardiovascular concerns, while Vivus Inc.’s Qnexa raised worries of birth defects related to one of its generic components and Arena Pharmaceuticals Inc.’s Lorquess bumped up against carcinogenicity concerns. Contrave is set to start a large cardiovascular outcomes study, which would delay its approval until 2014. But Qnexa and Lorquess could have a shot at getting approved in 2012. That’s assuming that no additional safety issues crop up. Given the track record in the obesity space, that’s definitely no guarantee.

The Rough Side of Town

While 2011 had its much-lauded drug approvals (as noted above), the year was not without its disappointments. Two promising areas of research suffered blows – Roche pulled out of the RNAi space, dumping a high-dollar collaboration with RNAi powerhouse Alnylam Inc., while Geron Inc. abandoned its position as embryonic stem cell pioneer to focus on a less-risky cancer drug. But the biggest disappointment of the year – as chosen by 41 percent of respondents to a BioWorld poll – was the slow sales of Dendreon Corp.’s prostate cancer vaccine Provenge (sipuleucel-T). Sales fell way below estimates, and, over the course of the year, Dendreon’s shares have lost about 80 percent of their value. The Seattle-based company has since retrenched and is hoping European approval, now pending, will help accelerate revenue growth. We’ll be watching in 2012.

And the Strange Bedfellows Award Goes to . . .

Probably one of the most bizarre deals ever in biotech was 2011’s short-lived merger agreement between Allos Therapeutics Inc. and AMAG Pharmaceuticals Inc. Having in common only commercially underperforming products – Allos’ Folotyn (pralatrexate) for peripheral T-cell lymphoma and AMAG's iron deficiency drug Feraheme (ferumoxytol) – execs from both firms tried hard to convince investors and analysts of the logic in combining the companies by pointing out a handful of “cost synergies.” But the merger was met with opposition from the get-go and even prompted hedge fund MSMB Capital Management to make an unsolicited bid for AMAG. Unsurprisingly, the deal was voted down by AMAG shareholders. Seriously, what were they thinking?

Well, that’s my list of headline-grabbing biotech news in 2011. But it’s hard to remember a whole year, and I’m sure I’ve forgotten something. What do you think were the biggest events in biotech in 2011?

]]>http://www.bioworld.com/perspectives/2011/12/28/the-good-the-bad-and-the-huh-a-2011-biotech-recap/feed/0Truth in Congressional Labelinghttp://www.bioworld.com/perspectives/2011/06/01/truth-in-congressional-labeling/
http://www.bioworld.com/perspectives/2011/06/01/truth-in-congressional-labeling/#commentsWed, 01 Jun 2011 19:28:45 +0000Mari Serebrovhttp://www.bioworld.com/perspectives/?p=181S. 990 was signed into law last week. At first glance, it looks like it extends the life of Small Business Administration programs that are near and dear to the bottom line of many small biotechs. But somewhere along its...

]]>S. 990 was signed into law last week. At first glance, it looks like it extends the life of Small Business Administration programs that are near and dear to the bottom line of many small biotechs.

But somewhere along its pat through the Senate, the bill was stripped of the language that would have extended the Small Business Innovation Research (SBIR) program through Sept. 30, 2012. In its place are a few short paragraphs renewing the Patriot Act. But the title of the bill remains “To provide for an additional temporary extension of programs under the Small Business Act and the Small Business Investment Act of 1958, and for other purposes.”

The Senate quickly came up with a new bill, S. 1082, with the same title, with language to keep SBIR funded for a few more months. The House was expected to approve it Tuesday – the day the current extension expires. To the casual observer, it will appear that Congress is passing a me-too bill.

Although it passed an extension, the Senate hasn’t given up on reauthorizing SBIR. It’s just that the floor debate has gotten bogged down on unrelated, or “off-label,” amendments. Lawmakers are among the first to point accusing fingers at biopharma about truth in labeling and off-label promotion. Maybe it’s time for them to stop gaming the system and lead by example.

]]>http://www.bioworld.com/perspectives/2011/06/01/truth-in-congressional-labeling/feed/0Biotech’s Emerging Gianthttp://www.bioworld.com/perspectives/2011/05/24/biotech%e2%80%99s-emerging-giant/
http://www.bioworld.com/perspectives/2011/05/24/biotech%e2%80%99s-emerging-giant/#commentsTue, 24 May 2011 20:08:20 +0000Lynn Yoffeehttp://www.bioworld.com/perspectives/?p=168While attending the China track at this year’s J.P. Morgan conference in January I sat next to a gentleman who was smiling as he scanned the jam-packed penthouse meeting room. Shooting him a questioning glance, he responded with “last year...

]]>While attending the China track at this year’s J.P. Morgan conference in January I sat next to a gentleman who was smiling as he scanned the jam-packed penthouse meeting room. Shooting him a questioning glance, he responded with “last year I attended there were five people here.” While I find it hard to believe a session on China was poorly attended, even a year ago, biotech and pharma executives were noticeably shoulder to shoulder, jockeying for position just a few months ago. Intensity over the Chinese market has certainly ramped up, to say the least.

As company after Chinese company pitched and presented, the Q&A at the end of each session seemed to steer away from the usual grilling about the companies’ worth and pipes. Instead, questions were focused on how to get a toehold in China. Where to start? How to deal with the government? Should we go it alone or partner with existing Chinese companies?

A few weeks ago a contingent of U.S. executives, led by the Biotechnology Industry Organization’s President and CEO Jim Greenwood, visited China. It was a sort of pregame show in advance of BIO’s first China International Partnering Conference in October in Shanghai. The execs came home awestruck. BioWorld Today’s Tom Wall wrote about their impressions from that visit in a new series dubbed Biotech’s Emerging Giant, with the first article found here: http://bit.ly/k8kcJ2

Joshua Boger, founder of Vertex Pharmaceuticals Inc., of Cambridge, Mass. visited a manufacturing site for starting materials for the company’s just-approved hepatitis C drug Incivek (telaprevir), and declared the facility to be so immaculate and well prepared that “You can eat off the floor. Everything over there is so much better coordinated.”

In part II of the series published today, Wall interviews executives who are advising slow comers to light a fire under their China strategies . . . if a company expects to be around in the next five to 10 years.

]]>It looked Monday as if two of biotech’s long-suffering names might finally be biting the dust.

Genta Inc. threw in the towel on beleaguered antisense drug Genasense (oblimersen sodium), after a final analysis of a Phase III melanoma trial – and a previous Phase III melanoma trial, and a Phase III chronic lymphocytic leukemia trial, and a Phase III multiple myeloma trial, and a melanoma approval bid, and a CLL approval bid, and a second CLL approval bid – failed.

Genta (OTCBB:GNTA) trades at two cents, and La Jolla (PinkSheets:LJPC) trades at a penny, which means fundraising efforts for either company will be difficult. But I wouldn’t throw these guys in the cart yet. They may not be shouting “I feel happy! I think I’ll go for a walk!” – but they aren’t dead yet either.

Why? Because biotechs just don’t die all that often. Their lead products fail, their back-up products fail . . . and they discover or in-license something else. They merge, they recapitalize, they keep going. The exception to this seems to have occurred in 2009 and 2010, when intense economic pressures actually squeezed a few dozen biotechs out of existence. Some folks say the consolidation isn’t over, but it doesn’t seem as intense as it was at this time last year. So if La Jolla and Genta survived this long, what’s to say they won’t find a way to keep going – for better or for worse?

]]>http://www.bioworld.com/perspectives/2011/05/23/ljpc-gnta-not-dead-yet/feed/0Race To Nowherehttp://www.bioworld.com/perspectives/2011/05/19/race-to-nowhere/
http://www.bioworld.com/perspectives/2011/05/19/race-to-nowhere/#commentsThu, 19 May 2011 18:42:02 +0000Anette Breindlhttp://www.bioworld.com/perspectives/?p=155Racial profiling – long in the realm of bad law enforcement – was criticized as bad medicine, too, in a recent paper by scientists from the Mount Sinai School of Medicine. The reason? As the authors put it, “cosmopolitan cities...

]]>Racial profiling – long in the realm of bad law enforcement – was criticized as bad medicine, too, in a recent paper by scientists from the Mount Sinai School of Medicine.

The reason? As the authors put it, “cosmopolitan cities now include many individuals whose genetic heritage is drawn from multiple continental origins.” In other words, there’s no such thing as racial purity.

In their paper, which was published in PLoS ONE and which you can find here (http://ow.ly/4YxK6) the team genotyped nearly 1,000 participants of Biobank, a program that collects DNA and plasma samples to aid in genomic and personalized medicine research from patients “representing the diverse communities surrounding the Mount Sinai Medical Center.”

Biobank participants are asked to self-identify as Caucasian, African-American, or Hispanic. But calling yourself something doesn’t make it so: the researchers found that depending on the criteria they used, they could justify racial categories that ranged from subdividing Hispanic samples into three separate groups, to tossing them into one group with the African American samples.

The authors concluded that their data “forcefully underscore the diminishing relevance of the descriptors currently used for the two principle minority groups in the US.” Scientists are sometimes criticized for spending good money to prove what grandma could have told you, and I do remember grandma telling me that you can’t judge a book by its cover. But she never mentioned that you can’t judge a book’s heart disease risk by its title.